Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)

on behalf of CISAI Study Group, L. Taramasso, Elena Ricci, Antonio Cascio, Laura Valsecchi, B. Menzaghi, N. Squillace, Paolo Maggi, G. V. De Socio, Chiara Dentone, G. Madeddu, Giovanni F. Pellicanò, L. Calza, Goffredo Angioni, Paolo Bonfanti, Antonio Di Biagio

Research output: Contribution to journalArticle

Abstract

Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Original languageEnglish
Article number21
JournalAIDS Research and Therapy
Volume16
Issue number1
DOIs
Publication statusPublished - Aug 26 2019

    Fingerprint

Keywords

  • Adverse events
  • CISAI
  • Darunavir/cobicistat
  • Dual
  • Durability
  • Tolerability

ASJC Scopus subject areas

  • Molecular Medicine
  • Virology
  • Pharmacology (medical)

Cite this

on behalf of CISAI Study Group, Taramasso, L., Ricci, E., Cascio, A., Valsecchi, L., Menzaghi, B., Squillace, N., Maggi, P., De Socio, G. V., Dentone, C., Madeddu, G., Pellicanò, G. F., Calza, L., Angioni, G., Bonfanti, P., & Di Biagio, A. (2019). Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA). AIDS Research and Therapy, 16(1), [21]. https://doi.org/10.1186/s12981-019-0236-0